Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions

Phase 4

Not yet recruiting

• Conditions: Hemodynamics Instability; Amobarbital Sodium
• Interventions: Drug: Amobarbital; Drug: Propofol

• Registration Number: NCT06385756
• Lead Sponsor: Tongji Hospital

Brief Summary

At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery.

The main questions it aims to answer are:

* whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients;

* whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction.

Participants will:

* Induction of anesthesia with the experimental drug or placebo；

* 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels；

* To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22
• Study Start: 2024-06-01
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• Age 40~60 years old；
• ASA Class I to II；
• The operation time was 1h~2h；
• BMI 18~25；
• Sign informed consent.

Exclusion Criteria

• Known allergy to narcotic drugs used in this study;
• Severe pulmonary insufficiency;
• Abnormal liver and kidney function；
• History of severe anemia and hematoporphyrin；
• History of asthma;
• Uncontrolled high blood pressure or diabetes;
• Pregnant and lactating women；
• Accompanied by cognitive impairment or inability to communicate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amobarbital-propofol group	Propofol	Participants were given amobarbital sodium 1 mg/kg 1 min before induction and propofol 1.5mg /kg following.
amobarbital-propofol group	Amobarbital	Participants were given amobarbital sodium 1 mg/kg 1 min before induction and propofol 1.5mg /kg following.
propofol group	Propofol	The propofol group was given the same volume of normal saline 1 min before induction, followed by propofol 2.5mg /kg.

Primary Outcome Measures

Name	Time	Method
Mean arterial pressure (MAP) during Induction of anesthesia	Up to 3 hours	MAP was recorded as the main index of hemodynamics during anesthesia induction

Secondary Outcome Measures

Name	Time	Method
MAP at different time points	Up to 3 hours	MAP at different time points (including before induction, tracheal intubation, cutting the skin, extubation)
Incidence of postoperative nausea and vomiting (ponv)	24 hours	The incidence of perioperative adverse reactions (ponv) was recorded